Trial Between Two Follow up Regimens With Different Test Intensity in Endometrial Cancer Treated Patients

Brief Title

Trial Between Two Follow up Regimens With Different Test Intensity in Endometrial Cancer Treated Patients

Official Title

Appropriateness Evaluation of Follow up Procedures in Gynaecology Oncology TOTEM Study: Multicentric Randomized Controlled Clinical Trial Between Two Follow up Regimens With Different Tests Intensity in Endometrial Cancer Treated Patients.

Brief Summary

      This study aims to compare two different follow up regimens with different test intensity in
      endometrial cancer treated patients.

      If eligibility criteria are satisfied and the written informed consensus is obtained,
      patients are stratified inside the centre according to their risk level:

        -  Group 1 : patients at low risk of recurrence [stage IA G1 and stage IA G2]

        -  Group 2 : patients at high-risk of recurrence [≥ stage IA G3] (Ethics Committee
           amendment of 14th September 2010, use new 2010 FIGO classification for endometrial
           cancer!)

      In each group patients will be randomized in two regimens of follow up:

        1. Minimalist (Arm 1)

        2. Intensive (Arm 2)

      Features of each arm are listed in "Arms" item.

Detailed Description

      The procedure for centralized randomization, with blocks of variable length, will take place
      within each layer with 1:1 ratio and will be implemented within the centralized database,
      with sequences generated by dedicated software. The recruitment and randomization has to be
      registered on the website (www.epiclin.cpo.it) no later than 20 days after histological
      examination has been received. If patients do not need any kind of adjuvant therapy they will
      start follow-up program according to the regimen chosen for them at randomization, if
      adjuvant therapy is needed the patient at first will be registered and the randomization will
      be deferred at the end of treatment.

      In presence of symptoms or signs detected during the clinical visit which may suppose a
      recurrence or in presence of abnormal tests, the clinician has to prescribe all medical tests
      and examinations required. The tests carried out in addition to follow-up scheduled program
      must be reported in the database. Nevertheless patients continue to be followed for the
      assessment of the performance status at 5 years, but the follow-up schedule is up to the
      clinician. An interim analysis is scheduled in 3.5 years starting from the beginning of
      recruitment (based on approximately 1 / 3 of the total expected events, when about 4 / 5
      cases have already been enrolled). Patients will be stratified by recruitment Center, by
      level of risk (calculated according to the stage of the disease, the histotype and the
      grading) and by type of treatment performed.

      The focus of the study is to:

        -  Compare the effect of two FU regimens on 5-years OS

        -  Evaluate the difference in diagnosis anticipation

        -  Evaluate the difference in terms of recurrences

        -  Describe the compliance and QoL of patients

        -  Evaluate the cost-effectiveness and the cost-utility

Study Type

Interventional

Primary Outcome

Overall survival

Secondary Outcome

 Progression-free survival

Condition

Endometrial Cancer

Intervention

Intensive/Low-Risk follow up (IA G1; IA G2)

Study Arms / Comparison Groups

 Intensive follow up

Description:  Intensive follow up in low-risk patients Intensive follow up in high-risk patients

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

September 2008

Completion Date

December 2020

Primary Completion Date

July 31, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  patients treated surgically for endometrial cancer, if in complete clinical remission
             confirmed by imaging stage FIGO I-IV

          -  no previous or concurrent neoplasia (with the exception of carcinoma in situ of the
             cervix and basalioma of the skin)

          -  other contemporaneous RCT may be allowed if there is not any restriction concerning
             follow up

          -  obtaining a written informed consensus before randomization

          -  age > 18 years

        Exclusion Criteria:

          -  presence of any psychological, familial, sociological or geographical condition that
             could potentially limit the compliance to the protocol and the follow-up planned: all
             these situations must be discussed with the patient before the randomization

          -  previous, concurrent or second malignancies endometrial carcinoma in the context of a
             hereditary syndrome

          -  conditions which contraindicate medical tests scheduled according to follow-up regimen

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Paolo Zola, MD, ,

Location Countries

Italy

Location Countries

Italy

Administrative Informations

NCT ID

NCT00916708

Organization ID

TOTEM

Responsible Party

Principal Investigator

Study Sponsor

Azienda Ospedaliera San Giovanni Battista

Collaborators

 Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Study Sponsor

Paolo Zola, MD, Principal Investigator, Azienda Ospedaliera Città della Salute e della Scienza di Torino - University of Turin

Verification Date

August 2018